Senior Quality Systems Specialist bei eGenesis
eGenesis · Cambridge, Vereinigte Staaten Von Amerika · On-site
- Optionales Büro in Cambridge
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
At eGenesis, our core values—innovation, collaboration, compassion, resilience, and passion—are at the center of how we work. We engineer hope and bring passion to everything we do. We collaborate and learn from one another, combining diverse expertise to tackle complex challenges. We innovate boldly, pushing boundaries and science to new heights. where no pig organ has gone before. With resilience, we navigate challenges and celebrate progress together. And in all we do, we lead with compassion—for our patients, our people, and our pigs.
POSITION SUMMARY
The Senior Quality Systems Specialist will be supporting the QA team to implement and manage Quality Systems supporting GMP Manufacturing and Testing across all eGenesis locations.
This position reports to the Associate Director of Quality Systems and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the Organization. This position will be in Cambridge, MA.
RESPONSIBILITIES
- Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of material to be used in clinical studies
- Ability to initiate, support and manage deviations and CAPAs ensuring timely closure across all sites
- Management and Administration of the Electronic Laboratory Notebook used for issuance and execution of Batch Records and Test Methods
- Responsible for Documentation Management (archival of physical records, management of Document Change Controls etc.)
- Responsible for Organization Training including administering training, managing training matrices, trending metrics and further developing the Training Program
- Participating in cross-functional teams to resolve quality related issues impacting manufacturing activities
- Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility
- Supporting the development of policies, processes, procedures, and controls ensuring they conform to established cGMP standards and regulatory requirements and guidelines
- Provide Quality Assurance support to many cross functional teams including Development, Manufacturing, Quality Control departments
- Provide mentoring and training to staff that are new to regulatory requirements and to facilitate their use of established quality systems
- Implement process improvements to enhance compliance and improve method and product quality processes (e.g. process tools creation, SOP revision, or enterprise systems implementation)
- Provide Quality Assurance support in reviewing/approving executed records in needed areas (Forms, Logbooks, Master Batch Records etc.)
- Perform duties regarding special projects, as assigned by QA Management
TECHNICAL QUALIFICATIONS
- Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management
- Non-degreed candidates with 7+ years combined of relevant GLP/GMP quality systems experience will be considered
- Knowledge of Quality Management Systems (QMS), CAPA processes, and audit procedures
- Familiarity with relevant regulations and standards (e.g., ISO, FDA, cGMP)
- Strong analytical, problem-solving, and communication skills
- Proficiency in using QA software tools and electronic Quality Management Systems (eQMS) is a plus
PREFERRED QUALIFICATIONS
- Experience in Qualio, Veeva and/or Benchling
- Experience in a start-up or small company environment
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